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cGDP definition

cGDP means the then current standards for all good distribution practices relevant to any product hereunder, including, as applicable, (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, (ii) European Directive 2013/C 68/01 and Eudralex 4, (iii) WHO TRS 957 Annex 5, (iv) USP <1079>, (v) any state or other local laws or regulations governing the licensing of distributors or manufacturers of pharmaceutical products or medical devices, and (vi) the equivalent applicable laws in any relevant country, each as may be amended and applicable from time to time.
cGDP or “GDP” All applicable then-current principles and guidelines of good distribution practices for medicinal products for human use as are required by applicable Regulatory Authorities or applicable law in the relevant jurisdiction, including as set forth in Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01), or in any similar set of laws, regulations, rules, or practices that are applicable in countries where the Product (including DS, DP or any Component of the Product) is or will be distributed under this Agreement or areas of the Territory in which the Products are or will be sold, including WHO Guidelines. “cGxP” GMP, GCP, and GDP

More Definitions of cGDP

cGDP means all laws, regulations, and industry practices relating to the handling, warehousing, and shipping of Products, including, the current Good Distribution Practices as specified in the most current versions of the United States Code of Federal Regulations (the CFR) or their replacement, and any other applicable laws, guidelines and/or regulations, including MSD’s reasonable requirements made in good faith relating to the warehousing and distribution for the Products (to the extent such MSD requirements are disclosed in writing to Distributor).
cGDP means the European current good distribution practice standards on the distribution of products, including requirements for transport, storage, distribution and wholesale as specified by Applicable Laws of the relevant Countries at the time of distribution conducted in accordance with this Agreement.
cGDP means Good Distribution Practice as defined in all applicable legislation and guidelines, including (in respect of countries in the Territory in the EU) directive 94/C 63/03 and associated guidelines;

Related to cGDP

  • GDPR means the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

  • EU GDPR means the General Data Protection Regulation ((EU) 2016/679), as it has effect in EU law.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans has the meaning set forth in Section 3.2.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.